Our team knows the importance of strategic analysis and decision-making in drug development. We come armed with a wealth of experience and a range of expertise to guide companies from emerging to Fortune 500 through the development continuum.
To support your drug development needs, MLM Labs provides tailored panels of biomarkers and cell-based pre-clinical assays, as well as biomarker testing services across the drug development continuum, from early proof-of-concept to commercial laboratory testing. Whether your drug is in preclinical development, or Phase I - IV clinical trials, biologic testing aids in the success rate of any drug development program. MLM Labs' scientific staff works with you to identify assays that can be used for early stage testing and that can be easily transitioned to the clinical trial setting. Testing at MLM Labs is performed in compliance with current Good Laboratory Practice (cGLP) guidelines.
In early drug development, biological testing:
- Describes pharmacodynamic effects and assists in dosing decisions during trial design
- Provides potential biologic signatures during early phase clinical trials that may correlate with drug efficacy.
- Yields essential ex vivo tests for drug or subject monitoring
- Reveals drug off-target effects that may be crucial for identifying new indications and for programmatic go/no-go decision-making
During late-stage clinical trials, biologic read-outs may support clinical outcomes and guide future trial design. As a result of their proven utility and future promise, biomarkers are increasingly embraced by the medical and regulatory community.
Core laboratory services for drug development:
- Laboratory and clinical assay development, validation, and testing
- Protocol review and tailored biomarker sampling
- Phase I through Phase IV on-site and off-site testing
- Development and deployment of sample collection and processing kits, central sample receipt, processing, testing and distribution
- Short-term and long-term bio-sample storage